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510(k) K802925

6-415 FILTER, ELEMENT, 170-C by Lifecare Services, Inc. — Product Code DSK

K802925 is an FDA 510(k) premarket notification submitted by Lifecare Services, Inc. for the device "6-415 FILTER, ELEMENT, 170-C". The FDA issued a decision of Substantially Equivalent on December 19, 1980. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Lifecare Services, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1980
Date Received
November 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

Other clearances by Lifecare Services, Inc.

  • K913423 — LIFECARE REMOTE ALARM II (January 30, 1992)
  • K912224 — LIFECARE CPAP-100 (September 23, 1991)
  • K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR (June 3, 1991)
  • K894779 — LIFECARE NASAL MASK KIT CAT. NO. 06-800 (January 12, 1990)
  • K895592 — FREEWAY NEBULIZER COMPRESSOR (November 21, 1989)
  • K894361 — LIFECARE PRESSURE ALARM CAT. NO. 34-010 (October 5, 1989)
  • K880378 — LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 (September 30, 1988)
  • K873570 — LIFECARE EXHALATION VALVE #06-699 (November 30, 1987)
  • K862212 — LIFECARE REMOTE ALARM #34-001 (June 23, 1986)
  • K842876 — PORTABLE LIFECARE VENTILATOR PLV-102 (August 29, 1984)

Other clearances for product code DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)

FDA data resources